BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKATER BILIARY

    MDR report key: 2113895 · Received May 18, 2011

    Report

    Report Number
    9613246-2011-00001
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 8, 2011
    Report Date
    May 16, 2011
    Manufacturer
    PBN MEDICALS DENMARK A/S
    Product Code
    DQX
    PMA / PMN Number
    K050873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS INSERTED IN THE GALL BLADDER ON THE (B)(6) - NO IRREGULARITIES WERE NOTED DURING THE PROCEDURE. ON (B)(6), THE PT RETURNED AS THE CATHETER APPEARED TO BE BLOCKED. THE CATHETER WAS REMOVED AND REPLACE WITH A COMPETITOR PRODUCT. SOME DAYS AFTER THE NEW CATHETER WAS INSERTED THE PT EXPIRED. THE CUSTOMER IS NOT BLAMING OUR PRODUCT AS THE PT WAS VERY ILL - THE DIAGNOSIS IS NOT YET KNOWN. THE SKATER BILIARY CATHETER WAS DISPOSED AFTER BEING REMOVED FROM THE PT, AND IT IS THEREFORE NOT POSSIBLE TO INVESTIGATE THE SPECIFIC PRODUCT. THERE WERE NO DEFECTS OR DEVIATIONS NOTED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    MD INSERTED A SKATER DRAINAGE CATHETER INTO A PT WHO WAS DISCHARGED TO HOME. MD STATED THAT THE PT WAS VERY ILL. PT RETURNED SEVERAL DAYS LATER AND IT WAS NOTED UPON RADIOGRAPH THAT THE DRAINAGE CATHETER WAS KINKED. THE CATHETER WAS REMOVED AND ANOTHER MFR'S CATHETER WAS INSERTED. THE PT EXPIRED SEVERAL DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKATER BILIARY F8 SKATER BILIARY STRING DQX PBN MEDICALS DENMARK A/S P372336

    Patients

    Seq Age Sex Outcome Treatment
    1